PLANNING · NPIESYNTHETIC DATARA LEAD · DRUG
Idea Evaluation & Regulatory Planning
The feedback, budget and market sequencing Business Development needs before the gate opens.
NPIE Workflow · Vildaglin 25 mg tablets
Business Development raises the idea and holds the gate. Every department promotes its feedback back to BD; the cell turns green only when BD accepts it.
BD
Initiate idea
BD
Preliminary review
BD SENIOR
Preliminary evaluation
7 DEPARTMENTS
Cross-functional feedback
BD
Feedback consolidation
MARKETING
Marketing review
BD HEAD
Business case approval
OUTSIDE SYSTEM
CEO approval by email
Regulatory Feedback · Vietnam
One feedback per market. Filled by the Regulatory Feedback Provider against the checklist held in the system.
MarketVietnam
Registration feasibleYes
Proposed categoryEthical drug
Dossier type requiredCTD
BE study requiredYes — supplier BE centre
Best case timeline730 days
Worst case timeline1,095 days
Dossier audit outcomeAccepted with gaps
Registration Budget Lines
The RA cost estimate that goes into the business case, including anything the dossier forces Mega to generate itself.
Registration and authority feesUSD 4,200
Legalisation of documentsUSD 1,850
COPP and CFS from EuropeEUR 2,000
Zone 4B stability re-studyUSD 18,500
Certified translation of annexesUSD 6,400
Reference samples and courierUSD 900
Zone 4B re-study and certified translation are the two lines that move most between markets.
Market Waves On One Idea
Vietnam was the primary market. Everything after it entered through an idea revision — each market then gets its own NPR, and each packaging configuration its own registration.
PRIMARYVietnamMarket that raised the idea and the forecastACTD
REV 1Myanmar · Nigeria · KenyaAdded by idea revision, re-evaluated per marketCTD
REV 2Tanzania · Uganda · Zambia · RwandaApproved in the same revision cycleCTD
REV 3EthiopiaNational permit — separate index built from the masterNATIONAL
Cross-Functional Inputs · NPIE-4471
Seven departments feed one idea record. Business Development holds the gate: a cell turns green only when BD accepts the feedback, not when the department submits it.
Regulatory AffairsACCEPTED
Feasibility per market, registration category, dossier type, BE need, timeline and cost.
N. Deshpandeclosed 4d
Market InputsACCEPTED
Target price, competitor set, forecast volume by pack configuration.
A. Pillaiclosed 6d
PatentsACCEPTED
Freedom-to-operate position and the earliest clear launch date per market.
D. Raoclosed 9d
Product DevelopmentSUBMITTED
In-house or outsourced, investment required, trial and commercial batch size.
Dr. V. Sathe2d with BD
ProductionSUBMITTED
Site capability, line availability, minimum order quantity.
K. Ramnath2d with BD
Quality ControlPENDING
Analytical method lead time, validation effort, project complexity rating.
unassigned11d open
PurchasePENDING
API supplier shortlist, landed cost, sample lead time.
R. Menon7d open
Idea Funnel · current financial year
Ideas raised, held, approved and killed. The drop between feedback and business case is where regulatory infeasibility surfaces.
Ideas raised184
Business Development, across all therapy areas.
Passed preliminary review141
43 closed at first read — no market, or already in the portfolio.
Cross-functional feedback complete98
Waiting on at least one department is the usual reason for the gap.
Business case consolidated61
Regulatory infeasibility surfaces here today — too late to be cheap.
Approved for development34
CEO approval still happens over email, outside the record.
Reached first registration22
Median 19 months from idea to first NPR submission.
Why Ideas Get Held
Reasons recorded on held or rejected ideas this year. Regulatory reasons are the ones the platform can predict before the business case is built.
27Dossier gap the supplier cannot closeUsually a missing study report or an incomplete DMF.PREDICTABLE
19Zone 4B stability data not availableExisting zone 2 data is not acceptable in the target market.PREDICTABLE
14Registration cost exceeds the business caseBE study or re-study cost turns a thin forecast negative.PREDICTABLE
11Patent position not clear until laterLaunch window closes before freedom to operate opens.EXTERNAL
8Site capability or capacityNo line available at the required batch size in the window.INTERNAL
6Market withdrew interestLocal team re-prioritised after the idea was raised.EXTERNAL
SYNTHETIC DATAAll data on this page is synthetic. Product names, brands, people, project numbers, suppliers, authorities, dates and figures were generated for demonstration and represent no real product, person, filing, supplier or company record. Structure and rules illustrate how the platform behaves, not any actual submission.